Demonstration of Near Zero Antibiotic Prescribing for Acute Bronchitis

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jeffrey A. Linder, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01240174
First received: November 10, 2010
Last updated: June 29, 2014
Last verified: June 2014
  Purpose

Studies show, guidelines state, and performance measures assert that antibiotic prescribing for uncomplicated acute bronchitis is inappropriate. However, clinicians prescribe antimicrobials in over 60% of the 22.5 million acute bronchitis visits in the United States each year. Previous successful interventions have only reduced the antimicrobial prescribing rate to 40% or 50%. It is unknown if the antimicrobial prescribing rate for acute bronchitis can be brought to near zero percent in actual practice while maintaining patient safety and satisfaction. The goal of this study is to develop an Electronic Health Record (EHR)-integrated algorithm for the diagnosis and treatment of adults with acute bronchitis with a goal of reducing the antibiotic prescribing rate to near zero percent.


Condition Intervention
Bronchitis
Cough
Behavioral: Demonstration of near zero antibiotic prescribing for patients with acute bronchitis

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Demonstration of Near Zero Antibiotic Prescribing for Acute Bronchitis

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Antibiotic prescribing rate [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    The antibiotic prescribing rate for patients with acute bronchitis


Secondary Outcome Measures:
  • Patient symptoms [ Time Frame: 21 days ] [ Designated as safety issue: No ]
  • Patient satisfaction [ Time Frame: 21 days ] [ Designated as safety issue: No ]
  • Patient safety [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Healthcare costs [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • The capture and description of the components that had the greatest effect on the antimicrobial prescribing rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: March 2011
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Demonstration of near zero antibiotic prescribing for patients with acute bronchitis
    A controlled, continuously-monitored, implementation of an EHR-integrated diagnosis and treatment algorithm for acute bronchitis in a large, diverse primary care practice.
Detailed Description:

We will use a multi-modal implementation - including computerized decision support, reporting tools, and clinician feedback - and quality improvement techniques to ensure adherence to the algorithm and reduce the antimicrobial prescribing rate to near zero percent. The duration of the intervention will be 4 years.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • first visit in 30 days, age 18-64, has a cough of less than 3 weeks duration

Exclusion Criteria:

  • infiltrate on chest x-ray, has chronic lung disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01240174

Locations
United States, Massachusetts
Brigham and Women's Hospital Jen Center for Primary Care
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Jeffrey A Linder, MD, MPH Brigham and Women's Hospital, Harvard Medical School
  More Information

No publications provided

Responsible Party: Jeffrey A. Linder, Associate Physician, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01240174     History of Changes
Other Study ID Numbers: 2010P001247
Study First Received: November 10, 2010
Last Updated: June 29, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
Antibiotic
Antimicrobial
Prescribing
Cough
Acute Bronchitis

Additional relevant MeSH terms:
Bronchitis
Acute Disease
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on September 30, 2014